MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER INC BAND AID BRAND KPP (KIZU POWER PAD) BANDAGES; DRESSING, WOUND, OCCLUSIVE

Model Number 4901730077002

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Inflammation (1932); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/25/2023

Event Type  Injury  

Manufacturer Narrative

Johnson & johnson consumer, inc.Is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which johnson & johnson consumer, inc.Has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, johnson & johnson consumer, inc.Or its employees that the report constitutes and admission that the device, johnson & johnson consumer, inc., or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.A4, a5: weight, and ethnicity and race were not provided for reporting.D1, d2, d3, d4: this report is for (band aid brand kizu power pad (kpp) large 12ct ap 4901730077002 4901730077002apa 4901730077002apa).Device is not distributed in the united states, but is similar to device marketed in the usa (band aid brand hydroseal bandages all purpose 1ct usa 381371175338 8137117533usa 8137117533usa).D4: udi #: (b)(4).Upc #: 4901730077002 expiration date: november 04, 2012 lot #: 0280c d9: device is not expected to be returned for manufacturer review/investigation h3, h4, h6: this product expired on november 04, 2012.The manufacturing site only maintains the records for one year after expiry date of the batch, therefore records are no longer available for review.Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.H6: health effect clinical code: e2326 also refers to consumer alleged about "inflammation was more intense (subsumed swelling, hot and pain)".E2402 refers to consumer "intentional misuse/off-label use" of the product e2402 refers to consumer "unintentional used expire product".The consumer used the product on a ¿wound about 3 cm deep¿ (interpreted as misuse; intentional) and also reported that product was expired (interpreted as expired product administered; coded to misuse; unintentional).It was reported that after applying the product to the wound ¿inflammation was more intense¿ (coded to inflammation; subsumed swelling, hot and pain).The consumer consulted hcp where she was told ¿hole was small but deep, thus the bacteria might have gotten inside the wound¿ and was treated with an unspecified ¿intravenous antibiotic¿ which was considered significant (coded to health effect impact code: unexpected medical intervention).No direct diagnosis of bacterial wound infection reported thus not considered.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

A 75 year old female consumer reported receiving a 3cm deep stab wound from a pine needle that stuck into the sole of consumer¿s foot.Consumer removed pine needle and thoroughly disinfected the wound.Consumer reported she rinsed the wound thoroughly with water and applied band aid brand kizu power pad to the wound.Consumer reported next morning, the affected area was swollen and had throbbing pain.Consumer reported she used band aid brand kizu power pad which was expired and thought this may have caused the symptoms and stopped using the product.Consumer sought medical intervention and visited a hospital.When she visited a hospital, she was told, ¿the hole was small but deep, thus the bacteria might have gotten inside the wound, and she covered it up with the product.It was also bad that the product was expired.¿ consumer was given intravenous antibiotic and was prescribed unknown oral antibiotic medication.At the time of this reporting the pain had subsided.Consumer was planning to visit the hospital on the day of this reporting.No further information was available.

• Brand Name: BAND AID BRAND KPP (KIZU POWER PAD) BANDAGES
• Type of Device: DRESSING, WOUND, OCCLUSIVE
• Manufacturer (Section D): JOHNSON & JOHNSON CONSUMER INC; 199 grandview rd; skillman NJ 08558 9418
• Manufacturer (Section G): COLOPLAST HUNGARY KFT.; h-4300 hyirbator; coloplast u.2 ; HU
• Manufacturer Contact: michael connaughton ; 199 grandview rd; skillman, NJ 08558-9418 ; 9086555919
• MDR Report Key: 18334441
• MDR Text Key: 330595493
• Report Number: 2214133-2023-00040
• Device Sequence Number: 1
• Product Code: NAD
• UDI-Device Identifier: 4901730077002
• UDI-Public: (01)4901730077002(17)121104(10)0280C
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/04/2012
• Device Model Number: 4901730077002
• Device Lot Number: 0280C
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 11/25/2023
• Initial Date FDA Received: 12/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/05/2009
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female